HGX · Class II · 21 CFR 884.5160

FDA Product Code HGX: Pump, Breast, Powered

Leading manufacturers include Shenzhen TPH Technology Co., Ltd., Shenzhen Root Innovation Technology Co., Ltd. and Medela, Inc..

255
Total
255
Cleared
167d
Avg days
1980
Since
255 devices
49–72 of 255
Cleared Aug 13, 2025
Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)
K252192
Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
Obstetrics & Gynecology · 30d
Cleared Aug 11, 2025
eufy Wearable Breast Pump S1 (T8D02)
K250207
Anker Innovations Limited
Obstetrics & Gynecology · 199d
Cleared Jul 31, 2025
Wearable Breast Pump (Model FS12A)
K250843
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 133d
Cleared Jul 15, 2025
Thrive 2-in-1 Breast Pump (Model P3)
K250350
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 158d
Cleared May 30, 2025
Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
K242725
Ningbo Youhe Electrical Appliance Technology Co., Ltd.
Obstetrics & Gynecology · 262d
Cleared May 30, 2025
Motif Aura Glow breast pump (Model Motif Aura Glow)
K250365
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 109d
Cleared May 30, 2025
Wearable Breast Pump (Model S21)
K250368
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 109d
Cleared Apr 21, 2025
Wearable breast pump (model S12A)
K243508
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 160d
Cleared Apr 17, 2025
Lacevo Wearable Breast Pump (Model S70)
K250829
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 29d
Cleared Apr 02, 2025
eufy Wearable Breast Pump S1 (T8D02) Model T8D02
K250152
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 71d
Cleared Mar 20, 2025
Ameda GLO Wearable Breast Pump (Model W8S)
K250463
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 30d
Cleared Feb 21, 2025
Wearable breast pump (model W8)
K242850
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 154d
Cleared Feb 06, 2025
VIVACE
K242111
Unimom.Co
Obstetrics & Gynecology · 202d
Cleared Dec 20, 2024
Momcozy Wearable Breast Pump (BP311)
K241680
Shenzhen Root Innovation Technology Co., Ltd.
Obstetrics & Gynecology · 192d
Cleared Dec 20, 2024
Momcozy Wearable Breast Pump (BP311)
K243629
Shenzhen Root Innovation Technology Co., Ltd.
Obstetrics & Gynecology · 25d
Cleared Dec 19, 2024
Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)
K241322
Joytech Healthcare Co. , Ltd.
Obstetrics & Gynecology · 223d
Cleared Oct 17, 2024
Electric Breast Pump (F5055)
K240218
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
Obstetrics & Gynecology · 265d
Cleared Sep 27, 2024
Elvie Stride 2
K242125
Chiaro Technology, Ltd.
Obstetrics & Gynecology · 70d
Cleared Sep 11, 2024
Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)
K241004
Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
Obstetrics & Gynecology · 152d
Cleared Aug 30, 2024
BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
K231969
Dongguanshi Yiyingmei Technology Co., Ltd.
Obstetrics & Gynecology · 424d
Cleared Jul 12, 2024
MilkMate Breast Pump (A0006)
K241705
Milkmate Products, Inc.
Obstetrics & Gynecology · 29d
Cleared Jul 01, 2024
Wearable Breast Pump (Model S32)
K240536
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 126d
Cleared Jun 27, 2024
Annabella Double Breast Pump (ADO-US23-1000)
K241506
Annabella Tech
Obstetrics & Gynecology · 30d
Cleared Jun 06, 2024
Wearable Breast Pump,Model S18
K232774
Ningbo Dearevery Electronic Technology Co., Ltd.
Obstetrics & Gynecology · 269d